UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044628 |
|---|---|
| Receipt number | R000050961 |
| Scientific Title | Infusion Time Differences and Patient Satisfaction with Intravenous Immunoglobulin(IVIg)for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Japan.(Time to Motion study) |
| Date of disclosure of the study information | 2021/06/25 |
| Last modified on | 2022/08/02 11:30:45 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Infusion Time Differences and Patient Satisfaction with Intravenous Immunoglobulin(IVIg)for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Japan.(Time to Motion study)
Acronym
Time to Motion study
Scientific Title
Infusion Time Differences and Patient Satisfaction with Intravenous Immunoglobulin(IVIg)for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) in Japan.(Time to Motion study)
Scientific Title:Acronym
Time to Motion study
Region
| Japan |
Condition
Condition
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study will describe current treatment patterns and patient satisfaction among CIDP patients with IVIg in Japan.
Basic objectives2
Others
Basic objectives -Others
The difference in infusion time (the preparation and infusion time) between 10% ready-to-use and 5% lyophilized IVIg products.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Measure and compare the infusion preparation time and infusion administration time of Privigen and Glovenin-I.
･Evaluate using the following questionnaire.
EQ-5D-5L,WPAI-GH,TSQM
･Understand the characteristics of CIDP diagnosis and treatment patterns.
1.Part A
Questionnaire answer(EQ-5D-5L,WPAI-GH,TSQM)
2.Part B
Measurement of infusion preparation time, measurement of infusion administration time
3.Treatment history of CIDP within the past year*
Dosage, rate, dosing time
4.Patient information at the registration
Date of informed consent, Sex [male or female], Occupation type, Weight,
Height, Body mass index (BMI), Age, Date of diagnosis of CIDP, Severity of CIDP [Hughes scale], Symptoms, Muscle atrophy, Response to steroid therapy, Complications, Concomitant medications*, Concomitant therapy*, etc.
*3:Including CIDP therapeutic drug
*4:Concomitant drug collects drug name, purpose of use, dosage, dosage form, frequency, route of administration, start date, end date (or ongoing), and concomitant therapy includes therapy name and purpose of use, frequency, start date, end date (or ongoing). If the research is discontinued in the middle, the date of discontinuation and the reason for the discontinuation will also be collected. In addition, we will collect data on the diagnosis of CIDP and the treatment status of patients from the principal investigator and the investigator.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
･Adults (aged 20 years and older) with CIDP.
･In principle, patients who have received regular maintenance IVIg with either a 5% lyophilized preparation (Glovenin-I) or a 10% liquid preparation (Privigen), with the same dose and infusion rate in the past three infusions, as well as no change to the regimens of other CIDP medications in this time. Maintenance IVIg therapy is defined as regular IVIg treatment that aims to prevent relapse of CIDP
･Have provided written informed consent to participate in the study.
Key exclusion criteria
･Participation in an interventional study of CIDP.
･Unsuitable for participation for other reasons, in the opinion of the treating physician.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Er-Win |
| Middle name | |
| Last name | Hew |
Organization
CSL Behring K.K
Division name
Medical Affairs
Zip code
107-0061
Address
1-2-3,Kitaaoyama,Minato-Ku,Tokyo,JAPAN
TEL
03-4213-0260
JPN.Medical_Affairs@cslbehring.com
Public contact
Name of contact person
| 1st name | Yoko |
| Middle name | |
| Last name | Konuki |
Organization
a2healthcare Corporation
Division name
Clinical Research Department
Zip code
112-0002
Address
1-4-1,Koishikawa,Bunkyo-Ku,Tokyo, JAPAN
TEL
03-3830-1075
Homepage URL
Time@a2healthcare.com
Sponsor or person
Institute
CSL Behring K.K
Medical Affairs
Institute
Department
Personal name
Funding Source
Organization
CSL Behring K.K
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Review Committee, Graduate School of Medicine, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JAPAN
Tel
043-222-7171
inohana-shien@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
千葉大学医学部附属病院(千葉県)、名古屋大学医学部附属病院(愛知県)、神戸大学医学部附属病院(兵庫県)、徳島大学病院(徳島県)、医療法人北祐会 北海道脳神経内科病院(北海道)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
23
Results
A total of 23 patients (10 in the 5% IVIg group and 13 in the 10% IVIg group) were participated in this study.
Total infusion time was significantly shorter in 10% IVIg than in 5% IVIg, with better scores on EQ-5D-5L score, indicating higher trend of QOL.
The results also confirmed that more than 70% of the principal investigators rated the patient's impression of the infusion time of 10% IVIg as "satisfactory" or "very satisfactory."
Results date posted
| 2022 | Year | 08 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 23 patients (10 in the 5% IVIg group and 13 in the 10% IVIg group) were participated in this study.
The mean age was 66.0 years in the 5% IVIg group and 54.9 years in the 10% IVIg group, and the median duration of CIDP medical history was long term 81.5months in the 5%IVIg group and 91months in the 10%IVIg group. As for the severity of CIDP (Hughes scale), proportion of patients with a score of 3 or higher was 50.0% in the 5% IVIg group and 7.7% in the 10% IVIg group. On the other hand, proportion of patients with asymmetrical CIDP symptoms was 60.0% in the 5% IVIg group and 15.4% in the 10% IVIg group. Since the 10% IVIg product used in this study became available in clinical practice in 2019, there were also differences in the median duration of IVIg therapy currently in use (approximately 5 years in the 5% IVIg group and approximately 2 years in the 10% IVIg group).
Participant flow
A total of 23 patients (10 in the 5% IVIg group and 13 in the 10% IVIg group) were participated in this study.
Adverse events
Not applicable because this study does not involve invasive procedures.
Outcome measures
･Measure and compare the infusion preparation time and infusion administration time of Privigen and Glovenin-I.
･Evaluate using the following questionnaire.
EQ-5D-5L,WPAI-GH,TSQM
･Understand the characteristics of CIDP diagnosis and treatment patterns.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 03 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 11 | Month | 25 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 10 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 03 | Day |
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
･Patient's information
･CIDP information
･Measure and compare the infusion preparation time and infusion administration time of Privigen and Glovenin-I.
･Evaluate using the following questionnaire.
EQ-5D-5L,WPAI-GH,TSQM
･Understand the characteristics of CIDP diagnosis and treatment patterns.
Management information
Registered date
| 2021 | Year | 06 | Month | 23 | Day |
Last modified on
| 2022 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050961
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
